Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Phytonadione
Drug ID BADD_D01770
Description Vitamin K1, also called phylloquinone or phytonadione, is a fat soluble vitamin.[L33319,L33345] Phylloquinone is a cofactor of the enzyme γ-carboxylase, which modifies and activates precursors to coagulation factors II, VII, IX, and X.[A234264,A234195,A234259] It is indicated in the treatment of coagulation disorders due to faulty formation of coagulation factors II, VII, IX, and X caused by deficiency or interference in the activity of vitamin K.[L33319] Phylloquinone has been synthesized since at least 1939,[A234384] and was approved by the FDA prior to 1955.[L33389]
Indications and Usage Oral phylloquinone is indicated to treat prothrombin deficiency caused by coumarin or indanedione derivatives; and hypoprothrombinemia secondary to antibacterial therapy, salicylates, or obstructive jaundice or biliary fistulas with concomitant bile salt administration.[L33345] Parenteral (intravenous, intramuscular, and subcutaneous) phylloquinone is indicated to treat coagulation disorders due to faulty formation of coagulation factors II, VII, IX, and X caused by vitamin K deficiency or some interference with vitamin K activity.[L33319] These indications include the above indications as well as hypoprothrombinemia secondary to sprue, ulcerative colitis, celiac disease, intestinal resection, pancreatic cystic fibrosis, or regional enteritis; or hypoprothrombinemia caused by interference with vitamin k metabolism.[L33319]
Marketing Status approved; investigational
ATC Code B02BA01
DrugBank ID DB01022
KEGG ID D00148
MeSH ID D010837
PubChem ID 5284607
TTD Drug ID D00FSV
NDC Product Code 0904-6882; 14501-0027; 76329-1240; 42413-0192; 76339-107; 16714-973; 60687-381; 33656-0010; 52221-124; 76055-0006; 0404-9969; 0409-9157; 63238-4300; 52584-405; 70710-1014; 0409-9158; 69238-1051; 49812-0232; 0404-9935; 69097-709; 65571-0028; 52584-046; 69097-708; 14593-912; 70771-1318; 43598-405
UNII A034SE7857
Synonyms Vitamin K 1 | Phytonadione | Vitamin K1 | Phytomenadione | Phylloquinone | Phyllohydroquinone | Aquamephyton | Konakion
Chemical Information
Molecular Formula C31H46O2
CAS Registry Number 79083-00-4
SMILES CC1=C(C(=O)C2=CC=CC=C2C1=O)CC=C(C)CCCC(C)CCCC(C)CCCC(C)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Atrophy08.03.04.001--Not Available
Cyanosis23.06.04.005; 02.11.04.004; 24.03.01.007; 22.02.02.007--
Death08.04.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Erythema23.03.06.001--Not Available
Flushing23.06.05.003; 08.01.03.025; 24.03.01.002--
Heart rate increased13.14.04.002--Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.003--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hypotension24.06.03.002--
Immune system disorder10.02.01.001--Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Injection site reaction12.07.03.015; 08.02.03.014--
Necrosis08.03.03.001; 24.04.02.006--Not Available
Pain08.01.08.004--
Phlebitis24.12.03.004; 12.02.01.002--
Pruritus23.03.12.001--
Pulse abnormal13.14.04.004--Not Available
Pulse pressure decreased13.14.04.008--Not Available
Rash erythematous23.03.13.029--Not Available
Scleroderma23.03.02.005; 15.06.01.002; 10.04.07.001--Not Available
Swelling08.01.03.015--Not Available
Induration08.01.03.020--Not Available
Inflammation10.02.01.089; 08.01.05.007--Not Available
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